Publications by authors named "Laura L Fernandes"

Article Synopsis
  • - The collaboration aimed to analyze real-world data (RWD) to better understand treatment responses in metastatic non-small cell lung cancer (mNSCLC) patients, particularly focusing on the challenges of assessing real-world treatment outcomes.
  • - A retrospective observational study was conducted using data from several electronic health record companies that included information from 200 patients treated with a standard chemotherapy protocol, assessing key response metrics such as real-world response rate and overall survival.
  • - Results indicated that while clinician assessments were consistent across data sources, there was variability in imaging data and the duration of response; overall, the study confirmed the potential to harmonize diverse data sources for evaluating treatment responses in mNSCLC patients.
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Article Synopsis
  • - This study investigated the characteristics and treatment outcomes of patients with refractory or relapsed diffuse large B-cell lymphoma (R/R-DLBCL) after initial treatment with the R-CHOP regimen, noting that up to 50% of patients do not respond satisfactorily.
  • - A total of 1,347 patients were included, showing that while 25.2% went on to second-line therapy, survival rates decreased significantly with each successive line of treatment, with 1-year overall survival rates at 88.5% for first-line but dropping to 62.4% for second-line.
  • - The findings highlight a significant need for new and effective treatment options for R/R-DLBCL, as current therapies yield
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Introduction/ Background: Surgical resection remains standard of care for patients with early-stage non-small cell lung cancer (NSCLC), but research shows that adjuvant therapy can reduce the risk of disease recurrence. Our objective was to characterize disease-free survival (DFS) using real-world data.

Materials And Methods: This was a retrospective study using the COTA real-world database derived from electronic health records in the United States (US).

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The narrow eligibility criteria may contribute to the underrepresentation of racial and ethnic subgroups in cancer clinical trials. We conducted a retrospective pooled analysis of multicenter global clinical trials submitted to the US Food and Drug Administration between 2006 and 2019 to support the approval of the use of multiple myeloma (MM) therapies that analyze the rates and reasons for trial ineligibility based on race and ethnicity in MM clinical trials. Race and ethnicity were coded per Office of Management and Budget standards.

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This retrospective observational study evaluated racial disparities among Black and White patients with multiple myeloma (MM). We included patients from a longitudinal de-identified EHR-derived database who had ≥2 visits recorded on or after 1/1/2011, documented treatment, and race listed as White or Black. Black patients (n = 1172) were more likely female (54.

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African Americans (AAs) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also higher in AAs compared with White patients. AAs more commonly have immunoglobulin H translocations t(11;14) and t(14;16) compared with White patients.

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Over the past 13 years, there have been advances in characterizing the patient experience in oncology trials, primarily using patient-reported outcomes (PROs). This review aims to provide details on the PRO measures and analyses used in multiple myeloma (MM) registrational trials. We identified registrational trials supporting MM indications from 2007 to 2020 from FDA databases.

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On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Approval was based on the SOLAR-1 study, a randomized, double-blind, placebo-controlled trial of alpelisib plus fulvestrant versus placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.

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The development and review of combination drug regimens in oncology may present unique challenges to investigators and regulators. For regulatory approval of combination regimens, it is necessary to demonstrate the contribution of effect of each monotherapy to the overall combination. Alternative approaches to traditional designs may be needed to accelerate oncology drug development, for example, when combinations are substantially superior to available therapy, to reduce exposure to less effective therapies, and for drugs that are inactive as single agents and that in combination potentiate activity of another drug.

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Purpose: To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated with anti-programmed death protein 1 or ligand 1 (anti-PD-1/L1) antibodies.

Patients And Methods: We examined seven trials in 1,747 patients with metastatic or locally advanced urothelial cancer that led to approval of an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy, and two enrolled patients who were cisplatin ineligible.

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The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

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On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious mutation (germline and/or somatic)-associated advanced ovarian cancer who have been treated with two or more chemotherapies. The FDA also approved the FoundationFocus CDx test (Foundation Medicine, Inc.

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Selection of the maximum tolerated dose (MTD) as the recommended dose for registration trials based on a dose-escalation trial using variations of an MTD/3 + 3 design often occurs in the development of oncology products. The MTD/3 + 3 approach is not optimal and may result in recommended doses that are unacceptably toxic for many patients and in dose reduction/interruptions that might have an impact on effectiveness. Instead of the MTD/3 + 3 approach, the authors recommend an integrated approach.

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In addition to getting a preliminary assessment of efficacy, phase II trials can also help to determine dose(s) that have an acceptable toxicity profile over repeated cycles as well as identify subgroups with particularly poor toxicity profiles. Correct modeling of the dose-toxicity relationship in patients receiving multiple cycles of the same dose in oncology trials is crucial. A major challenge lies in taking advantage of the conditional nature of data collection, that is each cycle is observed conditional on having no previous toxicities on earlier cycles.

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Many Phase I trials in oncology involve multiple-dose administrations on the same patient over multiple cycles, with a typical cycle lasting 3 weeks and having about six cycles per patient with a goal to find the maximum tolerated dose (MTD) and study the dose-toxicity relationship. A patient's dose is unchanged over the cycles and the data are reduced to a binary endpoint and the occurrence of a toxicity and analyzed by considering the toxicity either from the first dose or from any cycle on the study. In this article, an alternative approach allowing an assessment of toxicity from each cycle and dose variations for patient over cycles is presented.

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Purpose: Doses actually delivered to the parotid glands during radiation therapy often exceed planned doses. We hypothesized that the delivered doses correlate better with parotid salivary output than the planned doses, used in all previous studies, and that determining these correlations will help make decisions regarding adaptive radiation therapy (ART) aimed at reducing the delivered doses.

Methods And Materials: In this prospective study, oropharyngeal cancer patients treated definitively with chemoirradiation underwent daily cone-beam computed tomography (CBCT) with clinical setup alignment based on the C2 posterior edge.

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Objectives/hypothesis: Surgical site infections (SSIs) are an important cause of morbidity and mortality after head and neck surgery. Our primary objective was to determine the efficacy of preoperative topical antimicrobial decolonization before head and neck surgery.

Study Design: Prospective, randomized controlled trial.

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